Quality Engineer

Venova Medical, Inc. is focused on improving hemodialysis outcomes by advancing vascular access solutions for patients in the United States. The company is developing next-generation vascular access systems designed to overcome both patient-level and system-level barriers to access creation. These solutions aim to enable rapidly functioning arteriovenous fistulas with fewer reinterventions, lower healthcare costs, and improved patient experiences. Venova Medical operates in a mission-driven environment where innovation and quality directly impact patient care and clinical efficiency.

Quality Engineer

RA/QA

Quality Assurance Manager

Exempt

The Quality Engineer will own and drive quality assurance activities tailored to a high-risk Class III medical device navigating clinical trials. Responsible for performing a wide variety of activities pertaining to quality assurance.

Assure compliance with applicable regulatory requirements and company policies by closely working with R&D, Operations, Clinical Affairs to ensure release of safe and effective device. Support and lead Quality objectives by planning, managing, implementing and ensuring continued compliance with the quality system.

• Support quality operations to ensure continued compliance with applicable regulations/standards and provide the necessary training to ensure awareness of personnel
• Contribute to quality initiatives and functions to ensure effectiveness of the quality management system, including but not limited to, product and process monitoring, data analysis and applying statistical techniques, audit support, purchasing and verification, control of equipment, etc.
• Perform quality functions such as procedure writing, inspection, testing and reviewing documents, lot history records, inspection records for accuracy and application of procedures or standards
• Assess opportunities for improvement and need for changes to the quality system by systematically monitoring and reviewing data pertaining to the organization, product or process changes, non‑conforming product, changes to regulations/standards, complaints and feedback
• Perform gap assessment of external standards/regulations as needed.
• Coordinate and/or assist with Document Control activities such as supporting the entire process of initial release of documents and subsequent change process in accordance with established SOPs. Follows up on open Document Change Orders (DCOs) to ensure timely completion.
• Own and/or support activities pertaining to complaint handling, vigilance and medical device incident reporting to ensure compliance with the applicable regulations. Work cross functionally to help identify root cause and any necessary corrective actions.
• Qualify suppliers and monitor supplier performance to ensure product meets specified requirements
• Lead investigations, root cause analysis, and determination of required action to be taken in response to non‑conforming product or process (NCMR) using a risk based approach
• Own, drive and/or participate in CAPA process
• Assist in the development of dFMEAs (Design Failure Mode Effect Analysis) and pFMEAs (Process Failure Mode Effect Analysis) and control plans where required.
• Maintain traceability, identification, documentation and applicable records to provide evidence of product and processes meeting requirements
• Solve multidisciplinary engineering problems at the component through system level.
• Conduct testing utilizing existing test protocols or develop new ones as needed.
• Ensure adherence to FDA Quality Management System Regulation (QMSR) standards across the product lifecycle—from pre‑production quality assurance and…